Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control

NCT ID: NCT01543243

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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This study aims to examine

1. the feasibility
2. immediately
3. long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

Detailed Description

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This study is based on the guideline of falls management exercise programs (FaME) designed exercise from Skelton and Dinan.

The FAME program is structured so that four biocybernetic pillars are embedded in the three successive stages of training.

The biocybernetic pillars:

1. improving the balance
2. improvement in functional capacity
3. improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

1. Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
2. Training Gain: with the aim to improve functional abilities.
3. Maintaining the Gains: with the goal of muscle mass and bone density and introduce them to build complex multi-sensory exercises.

We started the FaME program with assistance from the pilot study, "Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Trial Registry: NCT01045746). It was found that a whole-body vibration with stochastic resonance (SR-WBV) enables that strength, coordination, and balance training while standing, in the exercise training gain phase is possible.

For this reason, this study will examine the feasibility and the immediately and long term effects of SR-WBV with 6 Hz, Noise 4 on postural control and strength in frail elderly.

Conditions

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Equilibration Disorder, Vestibular Nerve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 2

Group 2: immediate effect: T0, Stochastic resonance whole-body vibration B intervention, immediate T1 (one minute after intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration A intervention, immediate T3 (one minute after intervention)

Long term effect: T4, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T7

Group Type EXPERIMENTAL

Stochastic resonance whole-body vibration A

Intervention Type DEVICE

Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1.

Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.

Stochastic resonance whole-body vibration B

Intervention Type DEVICE

Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4.

Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.

Group 1

Group 1: immediate effects: T0, Stochastic resonance whole-body vibration A intervention, immediate T1 (one minute after Stochastic resonance whole-body vibration B intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration intervention, immediate T3 (one minute after Stochastic resonance whole-body vibration intervention)

long term effect: T4, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T5, 16 days wash-out period; T6, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T7

Group Type EXPERIMENTAL

Stochastic resonance whole-body vibration A

Intervention Type DEVICE

Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1.

Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.

Stochastic resonance whole-body vibration B

Intervention Type DEVICE

Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4.

Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.

Interventions

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Stochastic resonance whole-body vibration A

Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1.

Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.

Intervention Type DEVICE

Stochastic resonance whole-body vibration B

Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4.

Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.

Intervention Type DEVICE

Other Intervention Names

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SRT ZeptorĀ® med plus Noise SRT ZeptorĀ® med plus Noise

Eligibility Criteria

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Inclusion Criteria

* RAI (Resident Assessment Instrument) \>0
* live in canton Bern
* in terms of training load be resistant.

Exclusion Criteria

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute surgical scars
* seniors with prosthesis.
* alcoholic
* acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
* acute inflammation or infection tumors
* fresh surgical wounds
* severe migraine
* epilepsy
* acute severe pain
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

Bern University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Slavko Rogan, cand. PhD, PTMsc

PT MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Slavko Rogan, MSc

Role: STUDY_CHAIR

Bern University of Applied Science, Department Health

Lorenz Radlinger, PhD

Role: PRINCIPAL_INVESTIGATOR

Bern University of Applied Science, Department Health

Dietmar Schmidtbleicher, PhD, Prof.

Role: STUDY_DIRECTOR

Johann Wolfgang Goethe University Frankfurt am Main, Department Sport Science

Rob de Bie, PhD, Prof.

Role: STUDY_DIRECTOR

University Maastricht, Department Epidemiology

Eling D de Bruin, PhD, Prof.

Role: STUDY_DIRECTOR

Swiss Federal Institute of Technology Zurich, Department Human Movement Science

Locations

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Bern University of Applied Science, Department Health

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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Rogan S, Schmidtbleicher D, Radlinger L. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study. Aging Clin Exp Res. 2014 Oct;26(5):519-27. doi: 10.1007/s40520-014-0212-4. Epub 2014 Apr 4.

Reference Type RESULT
PMID: 24700493 (View on PubMed)

Rogan S, Radlinger L, Schmidtbleicher D, de Bie RA, de Bruin ED. Preliminary inconclusive results of a randomised double blinded cross-over pilot trial in long-term-care dwelling elderly assessing the feasibility of stochastic resonance whole-body vibration. Eur Rev Aging Phys Act. 2015 Oct 9;12:5. doi: 10.1186/s11556-015-0150-y. eCollection 2015.

Reference Type RESULT
PMID: 26865869 (View on PubMed)

Other Identifiers

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PhD pilot study 2

Identifier Type: -

Identifier Source: org_study_id

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